Health Problem: Osteoarthritis is the second most common disorder of the first metatarsophalangeal (MTP) joint. Osteoarthritis is characterized by the progressive loss of articular cartilage and development of osteophytes. Also referred to as hallux rigidus or hallux limitus depending upon the severity of joint dysfunction, the condition is characterized by pain and functional limitation that can range from mild to disabling. Although the exact prevalence is unknown, osteoarthritis of the first MTP joint has been reported to be present in 2.5% to 10% of adults.

Technology Description: The Cartiva Synthetic Cartilage Implant (SCI) device is a molded, cylindrical implant created from a biocompatible hydrogel made of polyvinyl alcohol and saline. Cartiva SCI has elastic and compressive mechanical properties similar to articular cartilage and maintains range of motion in the joint. The device is intended to replace focal areas of painful damaged cartilage in the first MTP joint.

Controversy: In arthrodesis, a standard and reliable procedure that is associated with long term pain relief, joint motion is eliminated. In addition, the procedure requires the patient to wear a hard cast for several weeks until bone union is confirmed by radiography. The Cartiva SCI maintains joint motion, does not require a hard cast, and allows for weight bearing when tolerated. It is unknown whether the Cartiva SCI is safe and whether the efficacy of the device is comparable to arthrodesis.

Key Questions:

  • Is the Cartiva SCI effective in treating degenerative or posttraumatic arthritis of the MTP joint?
  • How does the Cartiva SCI compare with clinical alternatives to treat degenerative or posttraumatic arthritis of the first MTP joint?
  • Is the Cartiva SCI safe for treating degenerative or posttraumatic arthritis of the first MTP joint?
  • Have definitive patient selection criteria been identified for the Cartiva SCI?

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